MAUDE Adverse Event Report: ARTHREX, INC. MENISCAL CINCH¿ II; POLYETHYLENE SYNTHETIC SUTURE

Model Number	MENISCAL CINCH¿ II
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 4th nov 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-4501, meniscal cinch¿ ii, the first implant was set properly but the second implant could not be set.This was detected during an arthroscopic patella reshaping, left knee meniscus suturing surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-4501.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-4501, batch 15274474, was received for evaluation.Upon visual evaluation, it was noted that the sutures were frayed and the implants were not returned with the device.The device's handle is broken.Functional testing was not performed due to the damage to the device.According to dfu-0156-eo g.Precautions.4: "particular attention should be paid to excessive manually applied forces when deploying the device to avoid over-deployment.6.Excessive movement of the device between deploying implant #1 and implant #2 can disrupt the deployment mechanism." the most likely cause is attributed to misuse due to user error of using excessive force to pry and/or leverage the device.

• Brand Name: MENISCAL CINCH¿ II
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23630289
• Report Number: 1220246-2025-05150
• Device Sequence Number: 18475953
• Product Code: GAT
• UDI-Device Identifier: 00888867299139
• UDI-Public: (01)00888867299139(11)240617(17)290531(10)15274474
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MENISCAL CINCH¿ II
• Device Catalogue Number: AR-4501
• Device Lot Number: 15274474
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown